In the pharmaceutical industry, it is extremely important that the correct label be placed upon containers, bottles or vials to correctly identify the pharmaceuticals contained therein. An incorrect label upon a container might easily result in the improper use of the contents. This could have severe consequences to a patient who receives the wrong drug or the wrong dosage of a drug because of an improper label on the container. Because of the seriousness of the consequences of mislabeling, automatic label verification as close to the filling and sealing station is desireable. The FDA is also mandating a two-person verification for cut labels supplied with pharmaceutical products.
A problem with manual inspection systems is that the accuracy of the method is dependent upon the individual inspectors, and the element of human error is always present. Furthermore, where a large number of containers or vials are being filled, such as in pharmaceutical manufacturing facilities, many persons may be required for the sole purpose of inspecting the labels. Such manual and visual inspection is not cost-effective and does not preclude human error.
Automated label inspection systems are known in the art. Such automated systems generally apply a label to a container or vial after if has been filled, sealed, and autoclaved. Generally, labeling of the vial is the last step, and several additional handling steps occur between the time the vial is filled with the pharmaceutical product and sealed, and the time that the label is applied. The possibility for mishandling during any of these further processing steps is always present.
In one known system, after the containers or vials are filled and sealed, and after the completion of any further processing, labels are applied to the bottles or vials. After the labels are applied, each container or vial is inspected to make sure that it does not have either an incorrect or improperly positioned label. The inspection is done with a scanning disk having a plurality of openings defined therethrough and a focusable optical system. A photocell is positioned to receive light passing through the optical system. A plurality of photographic facsimiles of the correct label are positioned in the openings in the scanning disk. As the containers pass the scanning disk, they are scanned and, if the label is improperly positioned or does not match the markings on the scanning disk, the bottle bearing the improperly positioned or incorrect label is rejected.
Another known apparatus uses an optical scanner to inspect articles following the labeling operation. The optical system detects the presence or absence of a label on each article. Unlabeled articles are removed from the conveyor line.
Another known prior art system applies printed matter to objects moving on a conveyor line by rotating the objects as they are carried under one or more print heads. The print heads are mounted for reciprocating movement adjacent to the path of the moving objects, and are moved at the same rate as the objects to present a stationary surface on the object for printing. Two objects can be printed at the same time. This system is, however, only a marking system, and does not attempt to verify if the mark has been properly applied and is readable. One known system of this type is disclosed in U.S. Pat. No. 5,207,153.
Finally, another known system marks and inspects articles, such as integrated circuit chips (IC's), traveling on an air track. Each IC is stopped at a fixed position printer station and is marked using a pad-ink transfer method. After each IC is marked, it is released and travels to a fixed vision system for inspection for verification and the mark is checked against a reference standard by a computerized, high-speed vision system using pattern recognition software. If the mark is determined to be sub-standard, the object is directed to a reject path. Acceptable parts pass on for further processing.
Of the known systems described above, the first two systems are concerned with inspecting a label which is applied to a container or vial after the container or vial has been filled, sealed and further processed. Generally, labeling of the vial is the last step, and several additional handling steps occur between the time the vial is filled with the pharmaceutical product and sealed, and the time that the label is applied. The possibility for mishandling during any of these further processing steps is not addressed by these known prior art systems, and although it may be believed that the correct label is being applied, nothing verifies whether the label is in fact being applied to a sealed vial having the correct contents. The third system described above is only concerned with applying a mark to an object traveling on a conveyor. In the fourth system described above, each object must be stopped on its path for both marking and inspection, which can slow down a production line unless several marking and inspection stations are utilized.
The present inventors recognized the shortcomings of the known prior art systems in failing to provide a system of marking a pharmaceutical vial or container immediately after it has been filled and sealed, and prior to any further processing, with an identification mark which identifies the pharmaceutical contents and other critical information regarding the contents of the container or vial and further failing to immediately verify the mark prior to any further processing.